does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about PRADAXA?
What is PRADAXA?
PRADAXA is a prescription medicine used to reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase your risk of a stroke. PRADAXA is a blood thinner medicine that lowers the chance of blood clots forming in your body.
It is not known if PRADAXA is safe and works in children.
Who should not take PRADAXA?
Do not take PRADAXA if you:
What should I tell my doctor before taking PRADAXA?
Before you take PRADAXA, tell your doctor if you:
How should I take PRADAXA?
What are the possible side effects of PRADAXA?
PRADAXA can cause serious side effects.
Common side effects of PRADAXA include:
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of PRADAXA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store PRADAXA?
Keep PRADAXA and all medicines out of the reach of children.
General information about PRADAXA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PRADAXA for a condition for which it was not prescribed. Do not give your PRADAXA to other people, even if they have the same symptoms. It may harm them.
This Medication Guide summarizes the most important information about PRADAXA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about PRADAXA that is written for health professionals.
For more information, go to www.PRADAXA.com or call 1-800-542-6257 or (TTY) 1-800-459-9906.
What are the ingredients in PRADAXA?
Active ingredient: dabigatran etexilate mesylate
Inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, FD&C Blue No. 2, FD&C Yellow No. 6, hypromellose, potassium chloride, titanium dioxide, and black edible ink.
Distributed by:Boehringer Ingelheim Pharmaceuticals, Inc.Ridgefield, CT 06877 USA
Issued October 2010This Medication Guide has been approved by the U.S. Food and Drug Administration.
©Copyright 2010 Boehringer Ingelheim Pharmaceuticals, Inc. ALL RIGHTS RESERVED
75461-01IT5060AJ202010
75457-01IT5400A
Coumadin® is a registered trademark for Bristol-Myers SquibbJantoven® is a registered trademark for USL PharmaPlavix® is a registered trademark of sanofi aventis Effient® is a registered trademark of Eli Lilly and Company
PRADAXA (dabigatran etexilate mesylate) 75 mg capsulesNDC 0597-0107-54
PRADAXA (dabigatran etexilate mesylate) 75 mg capsulesNDC 0597-0107-60
PRADAXA (dabigatran etexilate mesylate) 150 mg capsulesNDC 0597-0135-54
PRADAXA (dabigatran etexilate mesylate) 150 mg capsulesNDC 0597-0135-60
Manufacturer
Boehringer Ingelheim Pharmaceuticals Inc.
Active Ingredients
Source
U.S. National Library of Medicine
DailyMed
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